Bipolar Disorder in Late Life

Bipolar Disorder Clinical Trial

— BPD  

Official title:

Bipolar Disorder in Late Life (Evaluation of MRI Hyperintensities and DTI in Bipolar Disorder)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787930
• Other study ID #: Pro00007867
• Status: Completed
• Phase: N/A
• First received: November 6, 2008
• Last updated: July 3, 2014
• Start date: October 2005
• Est. completion date: December 2011

Study information

• Verified date: July 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to look at certain structural changes in the brain in people with bipolar disorder or those with a history of Bipolar disorder.

Description:

Individuals with bipolar disorder or those with a history of bipolar disorder may have certain structural changes in their brain. The purpose of this study is to look at those changes, as well as the assessment of risk factors for bipolar disorders, involving both social and psychological aspects of behavior, age, education, marital relations, nutrition, physical activity, etc., compared with persons not having bipolar disorder. These changes in the brain will be measured by Magnetic Resonance Imaging (MRI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. DSM-IV diagnosis of bipolar Disorder, Manic and mixed episodes.

2. 18 years of age and older, male or female, any race.

3. Capacity to give informed consent and follow study procedures.

Exclusion Criteria:

1. History of alcohol/drug dependence

2. Any metal or pacemaker in the body which precludes MRI

3. Pregnancy

4. Dementia or other primary psychiatric disorders including substance abuse/dependence, anxiety disorders, schizophrenia

5. For controls, numbers one through four above as well as any history of depression or the use of antidepressants

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Valproic Acid
Tablets, 250mg-3000mg

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania	Subject with acute mania were treated for 3 weeks with STEP-BD protocol using valproic acid as the primary intervention. Subject MRI's were evaluated for the presence of deep white matter hyperintensities (DWM) (>2 on the the Boyko Classification). Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions.	3 weeks	No
Primary	Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment	Subject were evaluated for relapse of their mood disorder and for the presence of DWM Hyperintensities (>2 on the the Boyko Classification. Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). Relapse was defined by protocol as either a MADRS scale >15 or a YMRS scale >15.	12 months	No
Secondary	Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment	Subject were evaluated for relapse of their mood disorder and for the presence of subcortical (SC) Hyperintensities (>2 on the the Boyko Classification). Boyko lesion classification system assesses SC hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS).	up to 12 months	No
Secondary	fa LOFC in Subjects Who Received Continuation Treatment	As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Left Orbitofrontal area (LOFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.	up to 12 months	No
Secondary	fa ROFC in Subjects Who Received Continuation Treatment	As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Right Orbitofrontal area (ROFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.	up to 12 months	No